Wockhardt Limited
This drug manufacturing facility is registered with the FDA by Wockhardt Bio Ag. ProPublica was able to identify at least 11 generic drugs that have been manufactured at this facility.
Facility Under Import Ban
This facility was on the FDA's import ban list last time we checked (November 2025), relating to failures in good manufacturing practices.
The following drug(s) were exempted from the ban at that time: Enalapril Maleate (Antihypertensive - part II) (62OCA28
Facility Inspection History
The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- Mar 17, 2015Mar 17, 2015Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.11 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Inadequate number of personnelThe number of qualified personnel is inadequate to perform and supervise the manufacture, processing, and holding of each drug product.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 26, 2013Nov 26, 2013Import Ban
The FDA banned the import of medications from this facility.
An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country. - Jul 31, 2013Jul 31, 2013Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 17, 2010Dec 17, 2010Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.